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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007427
Receipt No. R000008724
Scientific Title A prospective co-hort study about efficacy and safety for sorafenib treatment in patients with advanced hepatocellular carcinoma.
Date of disclosure of the study information 2012/03/02
Last modified on 2012/09/19

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Basic information
Public title A prospective co-hort study about efficacy and safety for sorafenib treatment in patients with advanced hepatocellular carcinoma.
Acronym A prospective co-hort study about efficacy and safety for sorafenib treatment in patients with advanced hepatocellular carcinoma.
Scientific Title A prospective co-hort study about efficacy and safety for sorafenib treatment in patients with advanced hepatocellular carcinoma.
Scientific Title:Acronym A prospective co-hort study about efficacy and safety for sorafenib treatment in patients with advanced hepatocellular carcinoma.
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to prospectively assess the efficacy and safety in patients with advanced hepatocellular carcinoma treated with sorafenib.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome of this study is the overall survival time.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria The patient who can expect survival more than three months.
A case of EOCG performance status 0 or 1.
The patient that an effect of the previous treatment, a side effect are not carried over
A case (inspection within two weeks before registration) that enough main organ (including marrow, a heart, the liver, the kidney) functions are maintained.
More than WBC 2000/mm3
More than 8.5 g/dl of Hb
More than Platelet 50,000/mm3
Less than Child-Pugh score seven points
Total bilirubin. 2 mg/dl or less
There not being the abdominal dropsy that Control is impossible of, hepatic encephalopathy
Is less than Creatinine 1.5 mg/dl; or Creatinine Clearance more than 50ml/min
Ejection fraction more than 45% (heart trouble merger patient)
A PaO2 more than 60 mmHg (chronic lung disease patient)
Key exclusion criteria An infectious disease of the activity (but except the viral hepatitis)
An overlap cancer of the activity
A past of sensitivity to iodocontrast media
A pregnant woman, a nursing girl may be pregnant
The case that the medical attendant judged to be inappropriate as an object of the final examination for reasons of others
(problem cases such as a patient does not hear instructions or the support of the family not being provided)
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahito Nakano
Organization Kurume University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address 67 Asahi-machi, Kurume
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kurume University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Division of Gastroenterology, Department of Medicine
Kurume University School of Medicine
Institute
Department

Funding Source
Organization Division of Gastroenterology, Department of Medicine
Kurume University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 02 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2009 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observing

Management information
Registered date
2012 Year 03 Month 02 Day
Last modified on
2012 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008724

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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